Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of light therapy designed to help patients with progressive multiple sclerosis (MS), a condition that can cause increasing fatigue among other symptoms. The main goal of the study is to see if this light therapy is safe for participants and to learn more about how it might affect their fatigue. Currently, there are no approved treatments specifically for fatigue in MS, so this study could provide valuable insights into new ways to manage this challenging symptom.

To participate in the trial, you need to be at least 18 years old and have a diagnosis of primary or secondary progressive MS. You should also have been on a stable dose of an approved medication for MS for the past three months. However, if you have had any significant medical issues recently, are pregnant, or have made changes to your medications in the last few months, you may not be eligible. If you join the study, you can expect to undergo various assessments and treatments while the researchers monitor your response to the light therapy. This trial is currently recruiting participants, and it's a great opportunity to contribute to the understanding of fatigue management in MS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria
• • In the opinion of the investigator, able to complete study procedures
• • Epworth Sleepiness Scale (ESS) ≥ 9
• • Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening
• • Pharmacological and non-pharmacological mood and fatigue treatments must be stable for the previous three months prior to screening and must have intent to keep these stable for the duration of study treatment
• Exclusion Criteria:
• • Sleep onset latency under 15 minutes
• • Pharmacological and non-pharmacological mood and fatigue treatments changes within the previous three months prior to screening
• • Based on the Investigator's judgement, patients with a history of significant other medical condition that may interfere with the conduct of the study, or interpretation of the study results
• • History of any clinically significant abnormality in hematology, blood chemistry, or examination not resolved by the baseline visit which according to the investigator can interfere with study participation
• • Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the trial
• • Females who are pregnant, have a provided recent positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial
• • Patient taking melatonin analogues without appropriate washout, defined as five half-lives of the medication, or within 14 days of screening, whichever is longer
• • No new or adjusted prescription medication within 14 days of the baseline
• • An investigator verified MS relapse within the previous year
• • Presence of a gadolinium-enhancing demyelinating lesion within the last year
• • Optic neuritis within the previous 3 months
• • Sleep schedule changes as required by employment (night shifts)
• • Travel across two time zones within 3 months of study screening